ANZCTR search results

The primary objectives of the study is to examine the feasibility, safety and efficacy of cannabidiol (CBD) in the management of concurrent mood and cannabis use disorders in young people, in a randomized controlled study. Specifically, the study will assess recruitment rates, retention rates, adverse events, the quantity and frequency of cannabis use, and the impact of CBD on patient mental health outcomes and well-being. Current treatments for anxiety and depression are of limited efficacy in a considerable proportion of patients (30% of depressed patients are pharmacoresistant) and are associated with troublesome side effects that reduce compliance; the development of novel, improved therapeutic treatments would fill a considerable unmet medical need. CBD has emerged as one of the most promising candidates in treating psychiatric disorders. Research suggests that greater rates of mental health problems in cannabis users are related to increased use of high THC/low CBD varieties of cannabis. In various animal and human laboratory and clinical studies, CBD has been found to reduce the intoxicating and psychotomimetic effects of THC, while CBD given alone has also been found to relieve anxiety and nausea and to have anti-inflammatory and antipsychotic effects. Thirty participants (male and female) will be recruited over a period of 9 months. The study will be conducted in the Department of Addiction Medicine at St Vincent's Hospital Melbourne. Participants will complete an initial assessment as per normal clinical practice. Eligible participants will be contacted to attend a baseline assessment and informed consent.. Participants will be randomized into either a CBD or placebo treatment group for a period of 12 weeks with follow-up at 14 weeks. All participants will be offered up to 6 sessions of manualised psychotherapy as per standard clinical practice.

The primary purpose of the NOMINATOR research study is to determine if new techniques for gene sequencing can be used in the treatment of rare cancers. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with a rare cancer which has few standard treatment options and is associated with poor outcome. Study details: All participants enrolled in this trial will provide samples of blood and tumour tissue either via retrieval of stored tumour sample from another lab/biobank if this is available or by undergoing a biopsy procedure to obtain fresh samples of tumour. These samples will be used for the gene sequencing test. We will also collect health information from the participant (either via direct questioning by their doctor or from their medical records), in order to help researchers interpret the genomic sequencing results which are obtained from testing. A panel of cancer experts will review the genomic sequencing results and provide advice about treatments that could potentially be more effective as a result of those findings. The patient will then have the option to receive the results of this testing (this is optional), and their doctor may be able to use these tests results to better determine an effective treatment and management plan for their disease. It is hoped that understanding a cancer’s genomic profile may help doctors to select appropriate treatment options, according to the particular genomic profile of that person’s cancer. This trial will provide information on whether this is feasible in practice.

This pilot intervention was tested in a randomised controlled trial involving approximately 100 families. It involves an innovative intervention remotely-delivered to parents (via mobile phone text messaging and online) which aims to increase physical activity (active play) and reduce screentime in their young children (1-3 years of age). A wait-list control design was implemented where control families received the intervention following a wait-list period. This design involved data collection at 3 time points, baseline (0 weeks), post intervention (6 weeks) and follow up/post wait list control receiving intervention (12 weeks). Children's physical activity and time spent in screen-based behaviors was measured via parent proxy reported surveys and also measured objectively using accelerometers at the 3 time points throughout the study. Measures of parental physical activity-related parenting practices, confidence, knowledge and modelling (parents' own physical activity and screen viewing) were also collected by self report. Being a pilot-trial, measures of feasibility and acceptability including retention and parent evaluation of the study components were also collected.

The aims of the project are twofold 1. To determine the true Surgical Site Infection incidence in children following Paediatric Surgical operations at Lady Cilento Children's Hospital, using parent-taken photographs of the wounds that are then uploaded to a secure site for review. 2. To determine if this extension of hospital and departmental care alters parental perception of their engagement with the hospital, assessed via qualitative methods. This project is a pilot study, with a view to a larger 'all-comers' cohort study.

Study Design: This is a prospective, non-randomised observational study which will follow post operative progress of patients who have been diagnosed with symptomatic Epiretinal membrane and will undergo epiretinal membrane peeling surgery over a 12 month period. Population: 100 eligible subjects will be recruited from Sydney Retina Clinic & Day Surgery, Australia. Study Duration: The study will be conducted over 18 months (6-month recruitment period and 12 month treatment and follow up period). Primary Objective: To evaluate the rate and amount of macular functional recovery using visual acuity, MAIA microperimetry and visual functioning questionnaires and to correlate this with anatomical change on SD OCT over 12 months. The aim will also be to determine prognostic indicators of poor visual outcome post surgery. 3. The change of retinal function measured by Macular Integrity Assessment (MAIA) microperimetry (including central threshold, average threshold, fixation stability and macular integrity) at months 1, 3, 6 and 12 months. Secondary Objectives: 1. Mean change in visual acuity at months 1, 3, 6 and 12 compared to the baseline using snellens chart at 6m 2. Mean change in central macular thickness measured by SD-OCT at months 1, 3, 6 and 12 compared to the baseline

The purpose of this project is to conduct a randomised controlled trial (RCT) to evaluate an app-based intervention to reduce stress and improve wellbeing in young adults caring for a friend or relative with a physical or mental condition/disability. The Stress-Less Mobile App monitors stress responsiveness throughout the duration of the intervention, and uses this information to obtain a risk profile of stress responsiveness, which can be used to predict periods of greater risk of distress and illbeing. In instances where greater risk is identified, participants are recommended to use the intervention resources immediately. It is hypothesized that this guided use will lead to improvement in subjective wellbeing and stress coping appraisals, and additional weekly check-ins provided by the research team will improve cohort engagement throughout the intervention period.

This research project is being conducted to look at the safety, tolerability and pharmacokinetics (PK, how the human body processes a substance) of a ETX2514 when given to healthy volunteers intravenously as a single dose, and when given as multiple intravenous doses for up to 8 consecutive days. As it is anticipated that ETX2514 could be used as a treatment for Acinetobacter baumannii (a type of bacteria) infections, this project will also look at whether ETX2514 will interact with the current treatments for these infections when they are administered at the same time.

This study aims to determine the current practices of adults with cystic fibrosis in relation to exercise and airway clearance techniques in Australia. It will also examine the beliefs of these individuals regarding the use of exercise as a form of airway clearance. Potential demographic and disease-related variables will be examined to determine if they are related to the participants current practices and beliefs regarding exercise and airway clearance techniques.

Diabetes is one of Australia’s greatest health issues, affecting more than 1.5 million Australians. One of the most devastating consequences of the disease is deterioration in foot health that, in severe cases, can lead to amputation. The feet are one of the first parts of the body to be affected by diabetes resulting in muscle weakness, poor circulation and a loss of sensitivity. Clearly, addressing the loss of foot muscle strength and restoring normal foot function will have important implications for the thousands of adults with diabetes who suffer from poor foot health. This study will determine the feasibility and effectiveness an exercise intervention that aims to increase foot muscle strength in people with diabetes. Upon recruitment into the project, participants will undergo a baseline assessment and will then be randomised into either a control or supervised exercise group. We hypothesise that after completing the resistance training program, participants will display improved foot muscle strength and decreased forefoot plantar pressures. The research will address critical health issues related to the ageing foot, with ancillary benefits in the context of falls prevention and foot care for at risk populations. The outcomes of the project will provide vital evidence to develop treatments to restore foot function to this vulnerable group within our community.

The aim of this study was to assess the effect of a lifestyle intervention based on behaviour change theories on liver enzymes and metabolic abnormalities in patients diagnosed with Non-alcoholic fatty liver disease (NAFLD) or Hepatitis C and not receiving anti-viral therapy. We hypothesised that if successful; such an intervention would reduce the metabolic risk profile of patients and thereby lead to a reduction in the drivers of hepatic steatosis and inflammation.